Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects

• Status: Completed
• Trial end date: 2003-02-26
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Considered generally healthy upon completion of medical history and physical

• examination, as judged by the investigator

• Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)

• Minimum body weight of 65 kg

• Fasting blood glucose between 3.8-6.0 mmol/L

• Glycohemoglobin (HbA1c) below 6.4 %

• Non-smokers

Exclusion Criteria:

• Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator

• A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject

• History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)

• Hepatitis B or C

• Subjects with a first-degree relative with diabetes mellitus

• Known or suspected allergy to trial product or related products

• Smoking during the past three months